Symbiomix Therapeutics Announces Publication of Pivotal Data for
Investigational Solosec™ for the Treatment of Bacterial Vaginosis

Data included in publication submitted to FDA as part of
recently-accepted New Drug Application undergoing priority review

If approved, Solosec™ will be the first and only single-dose oral
therapy for BV

July 17, 2017 09:48 AM Eastern Time

NEWARK, N.J.--(EON: Enhanced Online News)--Symbiomix Therapeutics today announced the publication of positive data
from a pivotal clinical trial of single dose Solosec™ (secnidazole oral
granules) for the treatment of bacterial vaginosis (BV). [1] Data from
the randomized, double-blind, dose-ranging, placebo-controlled,
multi-center study (SYM-1219-201) were published in the August issue of Obstetrics
& Gynecology. Solosec™ is a potent, next-generation,
investigational 5-nitroimidazole antibiotic with enhanced
pharmacokinetic properties, and is the first and only single-dose oral
therapy in development for BV. Solosec™ is under investigation and the
safety or effectiveness of the product have not been established.

BV is the most prevalent gynecological infection in the U.S. among women
ages 15 to 44, with more than four million women treated annually.
[2,3,4] More than 50 percent of women treated for BV have a recurrence
within 12 months. [5] The most commonly prescribed oral BV treatment
regimen requires twice-a-day dosing for seven days. Adherence with the
current leading therapy for the treatment of BV has been shown to be
only approximately 50 percent. [6]

“Although there are several treatment regimens for BV, none provide the
benefit of a single oral dose combined with good efficacy,” said Sharon
L. Hillier, PhD, University of Pittsburgh and the Magee-Women’s Research
Institute and lead author on the publication. “The data suggest that
secnidazole may provide an exciting new option for women with BV.”

In the SYM-1219-201 study, women with BV were randomized to 1 or 2 g
secnidazole or placebo, each administered as a single oral dose. The
primary endpoint was clinical cure (normalization of discharge, amine
odor and clue cells) 21–30 days after treatment. In the modified
intent-to-treat (mITT) population of 188 women, clinical cure rates were
67.7% for 2 g secnidazole compared with 17.7% for placebo (p<.001). This
study enrolled frequent BV sufferers (≥4 episodes per year), which made
up 33% of the patients in the mITT cohort. The 2 g dose of secnidazole
provided the greatest efficacy and was well tolerated. [1]

“The results of this study provide a strong rationale for the expanded
development of Solosec™ and its potential as an important advancement in
the treatment of BV and potentially other women’s health infections,”
said David L. Stern, Symbiomix CEO. “We’re encouraged by these findings
as we continue to advance Solosec™ with U.S. regulatory authorities and
work towards our goal of bringing innovative medicines to market for
prevalent gynecologic infections that can have serious health
consequences.”

The U.S. Food and Drug Administration (FDA) accepted the New Drug
Application (NDA) for Solosec™ (secnidazole oral granules) in March
2017. In accordance with the FDA's priority six-month review
designation, the agency has established a user-fee goal date under the
Prescription Drug User Fee Act (PDUFA) of September 2017.

About Trial SYM-1219-201

SYM-1219-201 is a phase 2, randomized, double-blind, dose-ranging,
placebo-controlled, multi-center study to evaluate Solosec™ for the
treatment of BV. In the trial, women with BV who met all Amsel criteria
(characteristic discharge; pH 4.7 or greater; 20% or greater clue cells;
positive whiff test) were randomized one-to-one-to-one at 24 U.S.
centers to 1 or 2 g secnidazole compared with placebo. The primary
endpoint was clinical cure (normalization of discharge, amine odor, and
clue cells) 21–30 days after treatment. Secondary endpoints included
microbiologic cure, defined as a Nugent score of 0–3, and therapeutic
cure, defined as meeting criteria for both clinical and microbiologic
cure. The modified intent-to-treat was used for efficacy analyses and
included all randomized patients who met the enrollment criteria. [1]

Between May and September 2014, 215 patients were enrolled. The modified
intent-to-treat population included 188 women (median age 33 years; 32%
with four or more bacterial vaginosis episodes in the previous year)
with baseline Nugent scores 4 or greater. Clinical, microbiologic, and
therapeutic cure rates were 67.7%, 40.3%, and 40.3% for 2 g secnidazole
and 51.6%, 23.4%, and 21.9% for 1 g secnidazole compared with 17.7%,
6.5%, and 6.5% for placebo, respectively (p<.05 for secnidazole compared
with placebo; all endpoints). [1]

Treatment-emergent adverse events were reported in 19% (14/72), 13%
(9/71), and 10% (7/72) in the 2 g secnidazole, 1 g secnidazole, and
placebo groups, respectively. Infections were the most common events in
all treatment groups (6.3%), but were similar in incidence across the
three treatment groups. Vaginal yeast infections were infrequent,
occurring in seven women, five of whom received secnidazole. All
treatment-emergent adverse events were mild or moderate in intensity. No
serious adverse events were reported. [1]

About Bacterial Vaginosis (BV)

BV is the most prevalent gynecological infection in the U.S. among women
ages 15 to 44. [2,3] Today more than four million women are treated in
the U.S. for BV annually. [4] More than 50 percent of women treated for
BV have a recurrence within 12 months. [5] The U.S. Centers for Disease
Control and Prevention (CDC) has stated that BV can cause serious health
risks, including:

Increasing the risk of HIV transmission;

Increasing the risk of contracting other sexually transmitted
diseases, such as chlamydia and gonorrhea, which, if untreated, may
lead to pelvic inflammatory disease and infertility; and

In pregnant women, increasing the risk of delivering a baby too early.
[3]

BV disproportionately affects disadvantaged populations, including women
of color, and may contribute to persistent disparities in women’s health
outcomes. [7,8]

BV has a significant impact on the work productivity and quality-of-life
of affected women, with 60% of recurrent sufferers reporting a negative
impact on work attendance, job performance and productivity, and 95%
reporting a severe restriction in intimate partner relations. [9,10]

The current recommended regimen of a first-generation nitroimidazole
requires twice-a-day dosing for seven days for a total administration of
seven grams of drug. Adherence with the current leading therapy for the
treatment of BV has been shown to be only approximately 50 percent. [6]
Poor adherence to anti-infective therapy is a problem that increases
with the length and complexity of the drug regimen, and can lead to
treatment failures, recurrent disease and the more rapid development of
resistant microorganisms. [11] These, in turn, may lead to higher health
care costs, including increased out-of-pocket expenses, increased office
visits and tests, additional treatment costs, and lost productivity. [12]

About Symbiomix Therapeutics, LLC

Symbiomix (sim-bye-OH-mix) is a biopharmaceutical company bringing
innovative medicines to market for prevalent gynecological infections
that can have serious health consequences. The Company’s lead
investigational drug Solosec™ (secnidazole oral granules), a potent,
next-generation 5-nitroimidazole antibiotic, is anticipated to be the
first and only single-dose oral treatment approved for bacterial
vaginosis (BV). Symbiomix was founded in 2012 by a team of experienced
industry professionals and entrepreneurs and is backed by three of the
world’s leading healthcare venture capital firms: OrbiMed, F-Prime
Capital Partners, and HBM Partners. Symbiomix is based in New Jersey,
with additional offices in Maryland and Connecticut. Please visit https://symbiomix.com/
and follow the Company on LinkedIn
and Twitter
for more information.